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Off-label promotional speech ruled constitutional


U.S. Court of Appeals rules off-label promotional speech constitutional.

Last December, the U.S. Court of Appeals for the Second Circuit issued a landmark decision in United States v. Caronia, clarifying that while off-brand promotion of a drug may serve as evidence of its “intended use” under the misbranding provisions of the Food, Drug and Cosmetics Act (FDCA), off-brand promotion is not prohibited but rather protected speech under the First Amendment.

The genesis of the ruling was the 2009 conviction of Alfred Caronia, a sales representative hired to promote Xyrem, a central nervous system depressant approved for treating symptoms associated with narcolepsy. A federal investigation revealed that Caronia told prospective purchasers of Xyrem that the drug could also treat fibromyalgia, Parkinson’s disease and various sleep disorders-none of which were FDA-approved uses. 

Caronia was charged with violations of the FDCA’s misbranding provisions. Following a jury trial and resulting guilty verdict, he was convicted under the statute and sentenced to community service and probation.


On appeal, Caronia argued that the FDCA’s misbranding provisions violate the First Amendment by prohibiting truthful, nonmisleading speech regarding off-label drug uses. The Second Circuit addressed the argument with a two-step analysis: considering whether the FDCA prohibits off-brand promotional speech, and whether Caronia’s conviction was based on any activity other than truthful, non-misleading speech.

In evaluating the constitutionality of the FDCA’s misbranding provisions, the court observed that the FDCA’s prohibition on drug misbranding targets conduct-labeling a drug in a manner that is misleading, false or insufficient in light of the drug’s intended use, and/or introducing a mislabeled drug into the marketplace.

While acknowledging that a pharmaceutical representative’s promotion of a drug may serve as evidence of the intended use, the court determined that off-label promotional speech is not actionable under the statute. The court construed the statute narrowly, finding that an interpretation that extended the FDCA’s blanket prohibition on “misbranding” to promotional speech would violate First Amendment principles.

Having concluded that off-brand promotion is not prohibited under the FDCA, the Second Circuit then considered whether the evidence presented at trial established that Caronia had engaged in conduct other than off-brand promotion-it did not.

While the government argued that it only made reference to Caronia’s speech as evidence that he intended Xyrem to be prescribed for a non-approved use, the Second Circuit rejected the argument. The court reversed Caronia’s conviction under the FDCA, concluding that the theory which the conviction was based on-rather than the statute itself-was constitutionally flawed.

While providing conceptual clarity for courts and legal practitioners, the practical implications of the decision remain unknown.

Despite the holding that a blanket ban on off-brand promotional speech is unconstitutional, the possibility that some of the regulation of off-brand promotion could be constitutionally permissible remains open.

It remains to be decided whether speech regarding off-brand drug use may be restricted, and what restrictions would mean for the advancement of the medical industry. MHE

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